BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS)

    MDR report key: 11366540 · Received February 23, 2021

    Report

    Report Number
    2916596-2021-00567
    Event Type
    Injury
    Date Received
    February 23, 2021
    Date of Event
    January 23, 2021
    Report Date
    June 15, 2021
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024011224
    PMA / PMN Number
    P060040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORT OF SUSPECTED THROMBUS AND ELEVATED LACTATE DEHYDROGENASE (LDH) COULD NOT BE CONFIRMED DURING THIS INVESTIGATION. ADDITIONALLY, ALTHOUGH TRANSIENT ELEVATIONS IN PUMP POWER WERE CONFIRMED THROUGH LOG FILE ANALYSIS; A DIRECT CAUSE FOR THESE ELEVATIONS COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. A DIRECT CORRELATION BETWEEN THE DEVICE AND THE REPORTED EVENTS COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. THE SUBMITTED LOG FILES COLLECTIVELY CONTAINED DATA FROM 30NOV2020 TO 31JAN2021. THE PUMP REMAINED ABOVE THE LOW SPEED LIMIT FOR THE DURATION OF THE LOG FILES. ON 26JAN2021, INTERMITTENT ELEVATIONS IN POWER, AND CORRESPONDINGLY FLOW, WERE CAPTURED. POWER AND FLOW APPEARED TO RETURN TO BASELINE ON 27JAN2021. THE LOG FILES APPEARED TO SHOW THE SYSTEM OPERATING AS INTENDED. MULTIPLE REQUESTS FOR ADDITIONAL INFORMATION WERE ISSUED TO THE CUSTOMER; HOWEVER, NO FURTHER INFORMATION WAS PROVIDED. THE PATIENT ULTIMATELY UNDERWENT A PUMP EXCHANGE ON (B)(6) 2021 (REFER TO MANUFACTURER'S REPORT NUMBER 2916596-2021-01194). THE HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU) (REV. C) IS CURRENTLY AVAILABLE. SECTION 1 ¿INTRODUCTION¿ OF THIS DOCUMENT ADDRESSES PUMP SPEED, POWER, AND FLOW AND EXPLAINS THAT PUMP POWER IS A DIRECT MEASUREMENT OF MOTOR VOLTAGE AND CURRENT AND THAT CHANGES IN PUMP SPEED, FLOW, OR PHYSIOLOGICAL DEMAND CAN AFFECT PUMP POWER. THIS SECTION ALSO LISTS DEVICE THROMBOSIS AND HEMOLYSIS AS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH USE OF THE HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM. SECTION 4 ¿SYSTEM MONITOR¿ EXPLAINS THAT PULSATILITY INDEX (PI) EVENTS ARE ASSUMED BY THE SYSTEM DURING CASES WHEN THERE ARE SUDDEN AND SUBSTANTIAL CHANGES IN THE PULSATILITY INDEX. IF THE SYSTEM DETECTS A PI EVENT, THE PUMP SPEED AUTOMATICALLY DROPS TO THE LOW SPEED LIMIT AND SLOWLY RAMPS BACK UP AT A RATE OF 100 RPM PER SECOND TO THE FIXED SPEED SETPOINT. SECTION 6 "PATIENT CARE AND MANAGEMENT" EXPLAINS THAT PUMP PERFORMANCE IS SENSITIVE TO CHANGES IN SYSTEMIC VASCULAR RESISTANCE AND LEFT VENTRICULAR FILLING. THIS SECTION ALSO OUTLINES INDICATIONS OF THROMBUS AND HOW TO RESPOND TO SUCH EVENTS, AND PROVIDES INFORMATION ON ANTICOAGULATION, INCLUDING RECOMMENDED INTERNATIONAL NORMALIZED RATIO (INR) VALUES. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR VAD-19004 WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT STARTED HAVING INCREASED POWERS TO 8-9 WATTS (W) AND FLOWS UP TO 12 LITERS PER MINUTE (LPM). THE PATIENT'S LACTATE DEHYDROGENASE (LDH) LEVELS WERE UP TO 1000. THROMBOSIS WAS SUSPECTED AND THE PATIENT WAS ADMITTED TO THE HOSPITAL. A LOG FILE ANALYSIS SHOWED BASELINE POWERS STARTING (B)(6) 2021. THERE WERE POWER ELEVATIONS ON (B)(6) 2021 AND NO FURTHER UNUSUAL EVENTS WERE NOTED. THE PATIENT'S LDH REACHED THE 900S ON (B)(6) 2021. THE PATIENT RECEIVED TISSUE PLASMINOGEN ACTIVATOR (TPA) FOR PUMP THROMBOSIS. THEIR LDH LEVELS AND POWER REACHED NORMAL LEVELS. LOG FILE ANALYSIS ALSO NOTED THAT THE PATIENT HAS NOT CONSISTENTLY BEEN CONNECTING TO THE POWER MODULE/MOBILE POWER UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    265973 HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS) VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106015 00813024011224

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| R